The Clinical Trials Research Team in the Department of Pharmacotherapy successfully completed its first-ever clinical trial this past summer after eight years of managing more than 140 patients.
A second clinical trial with 36 patients has been underway for three years and the team is now recruiting patients for two additional trials it is starting in Spokane.
The team’s demonstrated proficiency in recruiting and caring for patients as well as following trial procedures and documenting findings has led to them being offered other trials, including their two new ones, which are their third and fourth trials.
“Our specialty is long-term cardiovascular outcome trials,” said Debbie Weeks, a nurse with 33 years experience who has worked more than 10 of those years with Dr. Carol Wysham, a Spokane endocrinologist and an adjunct research professor at the College who heads the team.
Weeks and Wysham and two other College employees with medical field backgrounds made up the team that handled the 142 patients for the National Institutes of Health (NIH) diabetes trial that ended over the summer. The team will participate in following its NIH study patients for another five years but what that will involve is yet to be determined.
WSU Spokane was one of more than 70 clinical trial sites for the NIH study which was designed to shed light on whether maintaining specific levels of blood sugar, blood pressure and cholesterol would reduce cardiovascular events such as heart attacks or strokes in persons with type 2 diabetes.
First Trial Had Sub-studies
The WSU team also participated in two sub-studies of the NIH trial – one that focused on the patients’ memory and the other on eye disease in relation to blood sugar, blood pressure and cholesterol goals. Study results have not yet been released.
The trial participants were required to follow certain regimens and report at regular intervals to the Health Sciences Building on the WSU Spokane Riverpoint Campus, where the team and their examination rooms are located. Patients are drawn to participate in clinical trials because of the free medical care, medications and extra attention that being part of a trial affords, Weeks said. The College of Pharmacy site rates high in being able to keep patients coming back, she said.
NIH Offers Second Trial
Because of that first trial – known as the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial – the NIH also enlisted the team’s participation in another national study that started in 2006 and will last five years. It compares how two different FDA-approved treatments for lowering cholesterol levels may reduce the risk of heart attacks, stroke and other cardiovascular complications. Co-sponsored by Abbott Laboratories, there are approximately 100 study sites for that trial and they will look at the medication Zocor® alone and also in conjunction with Niaspan®.
The two new clinical trials are both diabetes related. One is sponsored by Duke and Oxford universities and the other was developed by the Population Health Research Institute in Hamilton, Ontario, Canada, and offered to WSU through the University of Washington.
The Duke University trial will compare whether the medication Januvia® makes a difference in cardiovascular outcomes in diabetic patients. Funded by Merck Inc., the trial will have study sites in 33 countries and follow 14,000 patients for at least three years.
The Population Institute’s trial will test whether adding a thiazolidinedione medication to the drug regimen of a person with diabetes will reduce the risk of heart disease, and whether the addition of vitamin D will decrease the risk of death and/or the risk of developing cancer. Funded by GlaxoSmithKline, the trial will have sites in 29 countries and approximately 16,000 patients will be followed for up to 10 years.
Joshua J. Neumiller Joins Team
In addition to the new trials, the team has also added new member Joshua J. Neumiller, an assistant professor of pharmacy at WSU, and an experienced researcher and licensed pharmacist for the past four years. Neumiller is a certified diabetes educator, certified geriatric pharmacist and has been with the College of Pharmacy since graduating from the program four years ago.
Weeks got her national certification in clinical research more than 10 years ago and she renews that every two years through continuing education. She and the College’s finance officer completed an intensive training for managing clinical trial finances and they work closely together on trial budgets to ensure they do not cost the university money.
“Careful review of the trial protocol is necessary,” Weeks said. “When a trial is offered to you, you want to make sure you aren’t going to go broke before you say yes.”
More information is available on the team’s web page.